ACUMED TENSION BAND PIN— 510(k) K964500
Substantially EquivalentAcu Med, Inc.
FDA 510(k) clearance K964500 for ACUMED TENSION BAND PIN, Substantially Equivalent on 1996-12-09. Applicant: Acu Med, Inc.. Device class: 2.
Clearance details
- Applicant
- Acu Med, Inc.
- Product code
- Code HTY
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beaverton, OR, US
Recent devices under product code HTY
view allMore clearances from Acu Med, Inc.
view allAdverse events under product code HTY
product code HTY- Injury
- 544
- Total
- 544
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K964500
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K964500.
Data sourced from openFDA. This site is unofficial and independent of the FDA.